Doctors raise concerns over the safety of 'keepsake' ultrasound photos
At the Los Cerritos Center mall near Los Angeles, high-definition photos of a baby in the womb are on display. “Fall in love at first sight,” says the sign on the front of Cherished Memories, a boutique where pregnant women can undergo a $27 to $200 ultrasound not covered by insurance.
The Food and Drug Administration has repeatedly urged pregnant womento avoid medically unnecessary ultrasounds, saying it is aware of “several enterprises” in the U.S. that perform ultrasounds on pregnant women for entertainment’s sake and then sell the images as keepsake photographs and videos.
The warnings did little to slow the burgeoning trend. Cherished Memories, whose owners declined an interview, also has storefronts at two other Southern California malls. A competitor sells keepsake ultrasounds at a mall not far away in Lakewood. In California alone, at least 40 stores sell elective fetal ultrasounds, according to a FairWarning review of businesses advertised on Google or registered with the Secretary of State.
Outside California, it’s easy to find businesses that offer ultrasound sessions for the whole family to enjoy, along withframed take-home images and videos that can be used as decorations at baby showers or gender-reveal parties. Thanks to improved imaging technology, even some doctors’ offices are competing, with one upscale New York City practice advertising high-definition images of a baby’s hands, feet, and face to take home for an additional $200 not covered by insurance. The anti-abortion group Focus on the Family last year live-streamed one pregnant woman’s ultrasound in the middle of Times Square, using the popular advancement in sonography known as “4D” technology, or the high-definition 3D images turned into a video.
The widespread use of fetal ultrasounds for sentimental purposes reflects a misconception among patients, and even some medical providers, that repeated, long-term sonogram exposure is proven harmless. In fact, regulators and researchers have said for years that fetal ultrasound should be used prudently—about two for each complication-free, low-risk pregnancy, and only for diagnostic purposes—out of caution for the developing fetus.
The FDA’s warnings about keepsake clinics date back to the 1990s. As the FDAsaid in its most recent advisory in 2014, “ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissue.” The long-term health effects of this on a fetus, the FDA said, are “not known.”
Despite the repeated warnings, it’s unclear if the agency has ever backed them up with enforcement action. An agency spokeswoman said in an email that the “FDA could take action against manufacturers and certain other establishments who were promoting or advertising the sale or use of a prescription device without a prescription.” She said the FDA could also refer keepsake clinics to state licensing boards for possible action. But she refused to say if the agency has actually done so.
In most states, keepsake clinic operators can easily purchase ultrasound machines from eBay or other second-hand sources. Radiologists are particularly concerned that people without any medical training could be operating the machines unsafely or dispensing incorrect medical advice.
Last year, a Louisiana woman who visited one such clinic told a TV news station that the technician had ordered her to do jumping jacks to produce a clearer image, and then informed her that she was having a boy. She later learned she was, in fact, having a girl.
One expectant mother in North Carolina, who spoke on condition of anonymity, said she has undergone elective ultrasounds for peace of mind. “A lot of us rely on these places to get through nine months of anxiety and PTSD from pregnancy loss. Doctors will usually only let us see our babies twice—once at eight to 12 weeks and once around 20 weeks. The rest of the time we live in fear and panic.”
Ultrasound imaging uses high-frequency sound waves to view the inside of the body. Research into the health effects of ultrasound on fetuses remains controversial in the medical community because ultrasound scans are also regarded by obstetricians and radiologists as life-saving technology. The machines are assumed to be safe because they have been used for years and, unlike X-rays, do not emit any ionizing radiation. The image of a baby on a sonographer’s machine is synonymous in pop culture with a healthy pregnancy.
Dr. Pierre Mourad, a neurology professor at the University of Washington who specializes in ultrasound research, became interested in prenatal ultrasound about a decade ago, after he happened to be seated on a plane next to Dr. Bryan King, a psychiatrist who specializes in neurodevelopmental disorders at the University of California, San Francisco. They got into a discussion about whether prenatal ultrasound might have any relevance to autism.
At the time, Mourad was aware of research from Sweden that showed that men exposed to more frequent ultrasound scans in the womb were 32 percent more likely to be left-handed. The Swedish researchers cautioned that prenatal ultrasound scans were important, but should be used sparingly, at levels as low as possible.
But in 1992, at the request of machine manufacturers, the FDA allowed for an eight-fold increase in acoustical output in sonogram machines to improve the image quality. Most studies asserting the safety of prenatal ultrasound were conducted on the pre-1992 equipment, according to a 2008 paper by radiologists at the University of California, San Diego.The American Institute of Ultrasound in Medicine, which represents sonographers and health care providers, takes the position that there is “insufficient evidence” of a causal relationship between ultrasound and adverse effects in humans. Still, the group acknowledges that most available research is based on exposure conditions prior to 1992.
Talking it over during the plane ride, Mourad recalled King explaining to him that autistic children are also more likely to be left-handed. By the end of the flight, the two had drafted a research proposal investigating a link between post-1992 ultrasound machines and autism.
In 2013, Mourad, King and colleagues published their first paper on the topic in the journal Autism Research. They found that mice exposed to prenatal ultrasound for 30 minutes tended to be less social but more active. More controversially, in 2016, the team published a paper based on human data, also in Autism Research, saying that they found a correlation between the first trimester ultrasound and more severe symptoms in autistic boys.
Mourad and the other researchers argued that their findings supported the FDA’s longstanding guidance to limit prenatal ultrasound scans for strictly diagnostic purposes. Radiologists and other doctors nevertheless pushed back that the research didn’t prove causation and could cause women to avoid the exams altogether.
There’s little evidence that that has actually happened; most data suggests that many pregnant women are getting far more than they need, despite the potential risks. A 2013 study in the journal Seminars in Perinatology found that women experiencing low-risk pregnancies received a mean of 4.55 ultrasounds per pregnancy, “too many,” the fetal medicine specialist who authored the paper told the Wall Street Journal. In 2015, The Journal, citing insurance data, reported that women were receiving 5.2 fetal ultrasound scans per delivery, a 92 percent increase from 2004—a conservative estimate because it only included ultrasounds in doctors’ offices.
“Anecdotally, I have seen nothing but more ultrasounds every year that I’ve been in practice and more people doing ultrasounds, not just maternal fetal medicine specialists,” said Dr. Amber Samuel, a Houston-based obstetrician and a spokeswoman for the Society for Maternal Fetal-Medicine.
Mourad, the ultrasound researcher, said that keepsake ultrasounds are particularly troublesome because they last extended periods of time and tend to focus on capturing an image of the baby’s face, potentially exposing the brain to more ultrasound energy. Citing a “lack of enthusiasm” in the scientific community, Mourad stopped pursuing research into the potential health effects.
“I’ve given up on my ultrasound and autism research,” he said. “I wasn’t able to crack the nut of what it takes to get external funding for that research.”
He has since moved onto investigating ultrasound as a treatment tool for adults suffering from Alzheimer’s disease and multiple sclerosis. He added that fetal ultrasound scans are a “powerful tool” for diagnostic purposes, and should only be used as such.
Dr. Manuel Casanova, a neurologist at the University of South Carolina School of Medicine, became concerned about the increased use of fetal ultrasound after research from Yale scientists in 2006 found that prolonged and frequent exposure of pregnant mice caused brain abnormalities in the developing mouse fetuses. Casanova argued that most doctors aren’t taking the potential risks seriously enough.
“Most people believe that ultrasound is about taking pretty pictures of your baby,” Casanova told FairWarning. “You should use ultrasound for a specific reason. And even when using this thing, it should only be available after the first trimester, and for as little energy as possible, and as little time as possible. Those principles are not being pursued.”
Professional groups that stress the safety of ultrasound do so in ambiguous terms. For example, the American College of Obstetricians and Gynecologists said in an emailed statement: ”Ultrasound is safe and should be used appropriately. There are multiple indications for more than 2 ultrasounds. It is up to the physician to determine the frequency of ultrasounds.”
But the group also says in a policy paper that ”ultrasound energy delivered to the fetus cannot be assumed to be completely innocuous, and the possibility exists that such biological effects may be identified in the future.”
“One of the big questions that has been raised recently is, ‘Does ultrasound cause an increase in autism?’ Because in the last 20 years, autism spectrum disorders have increased tremendously, and so has the use of ultrasound,” said Dr. Jacques Abramowicz, an obstetrician and former chair of the bio-effects committee of the American Institute of Ultrasound in Medicine. But he said that there’s “no science” that proves a connection with autism. The prior studies on mice aren’t applicable to humans, he argued, because the exposure levels on the mice were far greater than what a human fetus would receive.
At the same time, Abramowicz said that even medical providers aren’t educated about the appropriate settings that they should maintain on ultrasound machines, which could present a safety concern to the fetus, given that the output of the machines increased so dramatically after 1992. “If I raise the temperature of the fetus in the first trimester, particularly by two, three degrees centigrade, that may be a big deal.”
On the website of Autism Speaks, the largest advocacy organization for people with autism in the U.S., one expert cautioned that no conclusions could be drawn from the University of Washington research. But he added that “this issue deserves further study to clarify future recommendations.”
More stringent regulations over the keepsake ultrasound industry are in place in some states. In California, state lawmakers passed the so-called “Tom Cruise” law in 2006, after the actor told Oprah Winfrey that he had purchased a home ultrasound machine for his then-wife Katie Holmes.
“The diagnostic sonography world went up in arms, like, ‘How easy is it to get these?’’ Katrina Stevenson, an ultrasound technician based in Long Beach, California, told FairWarning. The California law banned unlicensed medical professionals from purchasing ultrasound machines. The American College of Radiology applauded the measure but said the law also didn’t go far enough, because it didn’t stop licensed sonographers from opening entertainment ultrasound studios.
Three years later, Connecticut became the first state to enact such a ban, at the urging of the groups like American Institute of Ultrasound in Medicine. The institute said that keepsake clinics were worrisome for numerous reasons, including the “potential biological effects that could result from scanning for a prolonged period.”
Many of the keepsake clinics now operating across the country advertise that they use the Voluson, a machine developed by GE Healthcare that allows images to be collected in crisp, high-definition 3D, as well as the 4D video technology that GE says they pioneered. The technology can allow doctors to catch facial deformities such as a cleft palate, Samuel, the obstetrician, told FairWarning.
At keepsake clinics, 3D and 4D capabilities are a key selling point; the press team for GE Healthcare did not answer questions from FairWarning about the use of its machines for non-medical purposes.
Confusion over the safety of fetal ultrasounds is evidenced by conflicting statements from the keepsake industry. Forever Yours, which promotes itself as a “luxury’’ keepsake operation with several storefronts in Orange County, California, tells patients that it won’t perform any ultrasounds before the 13th week of pregnancy. “Any clinics offering heartbeat during the first trimester could be putting your baby at risk,” its website warns.
By contrast, Little Toes & Fingers, a keepsake clinic near Los Angeles, advertises on its website that it can perform heartbeat scans as early as 10 weeks into pregnancy. The Little Toes & Fingers website assures women that “routine scanning of all pregnancies is now normal throughout the United States.”
Treasured Moments, a keepsake ultrasound clinic that claims to have served over 25,000 customers at its two locations in Southern California, advertises “quick peek” ultrasound sessions for women who are between eight and 13 weeks pregnant. Women who visit in the first trimester are then eligible for a $50 discount for follow-up visits. The owners of Little Toes & Fingers and Treasured Moments did not responded to interview requests from FairWarning, and Forever Yours declined to comment.
Casanova, the University of South Carolina neurologist, said he found it particularly “offensive” that two of the businesses advertised promotions during “the most susceptible period, the first trimester.”
Katrina Stevenson, the licensed ultrasound technician in Long Beach, opened a modest keepsake clinic in 2014, hoping to find more enjoyable side work with pregnant women than in her night job mostly scanning sick adults.
Stevenson was aware that the FDA had told pregnant women to avoid keepsake ultrasound clinics, and said she understood the concern. When she researched the keepsake industry, she found “a lot of business owners were non-medical professionals. And they were hiring a lot of women who hadn’t even so much gone to an ultrasound program,” Stevenson said.
Stevenson was also concerned to find some online businesses advertising “unlimited” ultrasound packages to women; she limits the keepsake sessions to two per customer.
But Stevenson wasn’t aware of any research suggesting that first trimester ultrasound could affect brain development. In fact, she said that doctors often allow her to display pamphlets promoting her business in their offices. The ultrasound school she attended 15 years ago even sent her to an elective ultrasound studio for training, she recalled.
“When I went into this business, I had to think very hard and heavy. And I talked to radiologists that I work with. And I asked them, you know, are there dangers?” Stevenson told Fair Warning. “Their answer to me was no.”
FairWarning is a nonprofit news organization based in Southern California that focuses on public health, consumer, labor and environmental issues.